Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection

NCT ID: NCT03792386

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2019-07-15

Brief Summary

The combined use of Doppler ultrasound and fluoroscopy may increase efficacy and safety during cervical transforaminal epidural injection of steroid and local anaesthetic

The study will detect by which technique we have to start and confirm by the other to reach the favourable outcome.

Detailed Description

In a previous Ultrasound study involving the C5C6 levels, a performance time of 248.8 ± 82.7 seconds was reported. On the basis of these findings, a 30% difference in performance time would represent an effect size of 0.82 and would require 20 patients per group to achieve an alpha error of 0.05 and beta error of 0.1. For dropped cases; 5% will be added. So a total sample size of 64 patients (32 per group) will be required.

Statistical Analysis: will be performed using SPSS version 22 statistical software. For quantitative data, normality will be first assessed with the Shapiro test and then analyzed with the Student t-test. Data that will not have a normal distribution, as well as ordinal data, will be analyzed with the Mann-Whitney U test. For binomial data, Fisher exact test will be used. All P values presented will be 2-sided and values of less than 0.05 will be considered significant.

Conditions

Chronic Cervical Radicular Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ultrasound guidance with fluoroscopic confirmation

Patients in which the intervention will be performed using ultrasound guidance with fluoroscopic confirmation

Group Type: ACTIVE_COMPARATOR

Ultrasound guidance with fluoroscopic confirmation

Intervention Type: PROCEDURE

the cervical spine will be sonographically examined to determine the C7 transverse process then after lidocaine skin infiltration, a 22G spinal needle is directed towards the hypoechoic shadow of the nerve root using the in-plane technique. then 1ml of non-ionic contrast will be injected and AP and the oblique foraminal fluoroscopic view will be obtained. After confirmation of correct placement of the needle,(2ml, 8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.

Fluoroscopic guidance with ultrasonographic confirmation.

Patients in which intervention will be performed using fluoroscopic guidance with ultrasonographic confirmation.

Group Type: ACTIVE_COMPARATOR

Fluoroscopic guidance with ultrasonographic confirmation.

Intervention Type: PROCEDURE

After AP view, alignment or squaring of the target lower end plate, an oblique foraminal view is obtained. Following lidocaine 1% skin infiltration, a 22G spinal needle is directed towards the target foramen then, the superficial ultrasound probe will be applied to delineate the foramen. The needle will be advanced \~3mm towards the dorsal root ganglia under fluoroscopic guidance. After contrast confirmation of needle placement, 2ml,8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.

Interventions

Ultrasound guidance with fluoroscopic confirmation

the cervical spine will be sonographically examined to determine the C7 transverse process then after lidocaine skin infiltration, a 22G spinal needle is directed towards the hypoechoic shadow of the nerve root using the in-plane technique. then 1ml of non-ionic contrast will be injected and AP and the oblique foraminal fluoroscopic view will be obtained. After confirmation of correct placement of the needle,(2ml, 8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.

Intervention Type: PROCEDURE

Fluoroscopic guidance with ultrasonographic confirmation.

After AP view, alignment or squaring of the target lower end plate, an oblique foraminal view is obtained. Following lidocaine 1% skin infiltration, a 22G spinal needle is directed towards the target foramen then, the superficial ultrasound probe will be applied to delineate the foramen. The needle will be advanced \~3mm towards the dorsal root ganglia under fluoroscopic guidance. After contrast confirmation of needle placement, 2ml,8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients suffering from radicular discogenic pain
• Patients suffering from radicular foraminal pain Patients suffering from radicular pain secondary to spinal canal stenosis
• Patients suffering from radicular pain after failed cervical disc surgery
• Not responding to conservative management for at least 3 months
• Patients with recalcitrant symptoms after transforaminal steroid injection.
• American Society of Anesthesiology (ASA) from I to III

Exclusion Criteria

• Presence of local or systemic infection
• Coagulopathy
• Body mass index > 35
• Cervical spine fracture
• Myelopathy
• Malignancy
• Pregnancy
• Patients unable to communicate with the operator during the procedure or report their pain diary after it.
• Patients not responding to previous cervical transforaminal steroid injection or had any untoward effects.
• Allergy to any one of the used medications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enas A Abd el Motlb, MD

Role: STUDY_CHAIR

Associate Professor

Locations

Enas A Abd el Motlb

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

R/17.06.52

Identifier Type: -

Identifier Source: org_study_id